510(k) K082085
K082085 is an FDA 510(k) premarket notification submitted by Sebia for the device "CAPILLARYS IMMUNOTYPING, MODEL 2100". The FDA issued a decision of Substantially Equivalent on April 17, 2009. The device falls under product code CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M)), a Class II device regulated under 21 CFR 866.5510. Sebia has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2009
- Date Received
- July 23, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunoelectrophoretic, Immunoglobulins, (G, A, M)
- Device Class
- Class II
- Regulation Number
- 866.5510
- Review Panel
- IM
- Submission Type